Clinical trial updates

SLN124

  • Product Information

    Product Information

    Scientific name: SLN124
    Brand name: Ν/Α
    RESPONSIBLE: Silence Therapeutics

  • Clinical Trial/Study Information

    Clinical Trial/Study Information <em><sup>Last update: 22/6/2023</sup></em>

    Trial Name: GEMINI II
    Code: : NCT04718844
    Phase: 1b
    Eligible patient diagnosis: NTD β-thalassaemia or HbE/ β-thalassaemia (adults)
    No. of Patients enrolled: 56 (Last update: 22/6/2023)
    Study Sites: 20 Sites per country

    Anticipated completion date: September 2023
    Scope of the Study / Aim: Evaluation of safety and tolerability (adverse event nature and frequency) of single and multiple doses of SLN124

  • Regulatory Information

    Regulatory Information

    Status: Not Authorised

     

    Additional notable points:

    • EMA: Orphan Drug designation granted (2019)
    • FDA: Rare Pediatric Disease designation (2020) ; orphan drug designation (2020)
    • MHRA: N/A

Update: 20 December 2023

The multiple dose portion of the GEMINI II phase 1 study in non-transfusion dependent thalassemia patients was completed.

SLN124 was well tolerated at all doses with no safety issues identified.

While proof of mechanism has been established in healthy volunteers, the effects on indicators of iron metabolism were variable in this study population of heterogeneous thalassemia subjects.

The company is prioritizing R&D efforts on the ongoing PV program and does not have plans to advance development in thalassemia at this time.

Source: https://silence-therapeutics.com/investors/press-releases/press-releases-details/2023/Silence-Therapeutics-Highlights-Recent-Company-Progress-and-Reports-Third-Quarter-2023-Financial-Results/default.aspx

 

Update: 30 September 2023

  • Topline data is on track to be announced in Oct – Dec 2023.

Source: https://silence-therapeutics.com/investors/press-releases/press-releases-details/2023/Silence-Therapeutics-Reports-Second-Quarter-2023-Results/default.aspx

 

Update: 30 June 2023

  • Dosing in the multiple dose portion of the GEMINI II phase 1 study in thalassemia
    patients has been completed.
  • Topline data is on track to be announced in Oct – Dec 2023.

Source: https://silence-therapeutics.com/investors/press-releases/press-releasesdetails/2023/Silence-Therapeutics-Reports-First-Quarter-2023-Results/default.aspx


Update: 31 March 2023

Silence expects data from the ongoing phase 1 multiple dose study of SLN124 in thalassemia patients in the fourth quarter of 2023.

In March 2023, the dosing of the multiple dose portion of the GEMINI II phase 1 study of SLN124 in thalassemia patients was completed. Topline data will be announced in the fourth quarter of 2023.

Sources: https://www.businesswire.com/news/home/20230112005311/en/SilenceTherapeutics-Provides-SLN360-and-SLN124-Clinical-Program-Updates
https://www.businesswire.com/news/home/20230315005297/en/SilenceTherapeutics-Reports-Fourth-Quarter-and-Full-Year-2022-Results

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